Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03584022|
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Neuropathy Chronic Inflammatory Demyelinating Polyradiculoneuropathy Vasculitic Neuropathy (Disorder) Amyloidosis Hereditary Neuropathy Sarcoid Neuropathy||Device: Biopsy + Nerve Repair Procedure: Biopsy Only||Not Applicable|
Patients will be evaluated for eligibility and then, after gaining informed consent, the surgical procedure will be scheduled. Baseline evaluations include physical/neurological examination, nerve conduction study and ultrasonography of the sural nerve, and testing for erythrocyte sedimentation rate, C-reactive protein and complete blood counts (with white blood cell differential). Surgery is done in an operating room under local or monitored anesthesia, depending on patient preference. An incision will be made above the ankle. Immediately after the surgery, the patient will repeat the baseline physical/neurological exams, and sural nerve ultrasonography.
Participants will be evaluated either in the clinic or by phone on a regular basis and will be required to keep a journal and fill out symptom questionnaires for up to 12 months post-procedure.
Development of a grade 4 local reaction at any time will fulfill criteria for review by the Data and Safety Monitoring Board (DSMB) for implant removal and definition as a failure.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients planned for diagnostic sural nerve biopsy will be screened. Nerve conduction study of the sural nerve is part of standard of care for patients who are screened for the study. If the amplitude of sensory nerve action potential (SNAP) is equal to or greater than 2 μV and the patient meets the other inclusive criteria, the patient will be recruited to enter the study. Ultrasonography of the sural nerve will be conducted. If the diameter of the sural nerve is greater than 2.75mm, the patient will be assigned to the control group. If sural nerve diameter is equal to or smaller than 2.75mm, the patient will be randomized to either the control or study group. A study team member (clinical coordinator) will draw a number from an envelope that holds equal amount of odd and even numbers. If the number drawn is an odd number, the patient will be assigned to the control group. If the number drawn is an even number, the patient will be assigned to the intervention group.|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial|
|Actual Study Start Date :||November 9, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: Biopsy + Nerve Repair
Subjects will undergo standard sural nerve biopsy plus repair of the 6 cm nerve defect using a synthetic polymer (PCLF) nerve tube.
Device: Biopsy + Nerve Repair
During the standard sural nerve biopsy procedure, a single-use, biodegradable implant designed to repair damaged peripheral nerves will be used to repair the nerve. The MCNS1 is a hollow nerve tube made of poly(caprolactone-fumarate) (PCLF), to connect severed nerve ends and promote the growth of regenerating axons.
Sham Comparator: Biopsy Only
Subjects will undergo the same standard sural nerve biopsy procedure as the Experimental Group, but will not include the nerve repair.
Procedure: Biopsy Only
Standard sural nerve biopsy only, without nerve repair.
- Safety as determined by number of participants with post-surgical reactions [ Time Frame: up to 12 months post surgery ]
Post-surgical reactions will include evaluations of the following:
- Percussion tenderness at site of proximal stump or repair site;
- Skin redness at the site of biopsy (length and width measured with calipers);
- Development of mild or moderate swelling along the site (yes or no). It is anticipated that this will resolve to a lower grade or progress to grade 4.
- Development of severe swelling or pustules or evidence of tube extrusion or wound dehiscence.
- Neuropathic pain as measured by SNAP [ Time Frame: 3 months & 12 months ]Sensory nerve action potential (SNAP) will be measured at the ankle using small electric shocks and recording pads on the skin. This will be done by an experienced and board-certified electrophysiologist.
- Neuropathic pain as measured by visual analogue pain scale [ Time Frame: weekly, monthly for first 3 months, then 12 months ]The Visual Analogue Scale (VAS) consists of a straight line with the endpoints of 'No pain' and 'Pain as bad as it could possibly be'. The subject is asked to mark his or her pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark defines the subject's pain.
- Neuropathic pain as measured by visual analogue pain assessment questionnaire [ Time Frame: weekly, monthly for first 3 months, then 12 months ]Subjects will be asked to check all of the following that apply: 1) fever, 2) unexplained or new joint aches and pain, 3) increased skin redness at or near the site of the biopsy, 4) increased swelling at or near the site of the biopsy, 5) some degree of pain or discomfort at or near the site of the biopsy
- Neuroma formation [ Time Frame: 3 months & 12 months ]Non-invasive nerve ultrasound will be performed to determine neuroma formation
- Sensory nerve regeneration as measured by SNAP [ Time Frame: 3 months & 12 months ]The amplitude of sensory nerve action potential (SNAP) will be used to determine sensory nerve regeneration
- Sensory nerve regeneration as measured by ultrasound [ Time Frame: 3 months & 12 months ]Non-invasive nerve ultrasound will be performed to determine sensory nerve regeneration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584022
|Contact: Michelle Turner||507-284-1223||Turner.Michelle@mayo.edu|
|Contact: Jane Sultze||507-538-5523||Sultze.Jane@mayo.edu|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Anthony J Windebank, MD||Mayo Clinic|